MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunctions of the drive tube leak/break and centrifuge bowl leak/break.Since these reportable malfunctions are only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f120 was conducted.There were no non-conformance associated with this lot.This lot met all release requirements.A review of kit lot f120 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, drive tube leak/break, centrifuge bowl leak/break, and noise.No trends were detected for these complaint categories.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.

Event Description

The customer called to report a drive tube leak/break, a centrifuge bowl leak/break and noise that occurred during a treatment procedure.The customer stated that at about twenty five minutes into the treatment procedure, the patient heard a loud click sound and then a loud noise.The customer reported that there was a leak inside of the centrifuge chamber.The customer stated that the instrument was immediately turned off and the patient was disconnected.The customer reported that the treatment was aborted with no return of blood/products to the patient.The customer stated that the patient was in stable condition and was not affected by the incident.The customer reported that no medical intervention was required.In a follow up with the customer on (b)(6) 2017, the customer stated that the drive tube had broken off from the centrifuge bowl and that the centrifuge bowl had shattered.The customer reported that the kit had been discarded.The kit was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6966993
• MDR Text Key: 90864208
• Report Number: 2523595-2017-00177
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1